- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT03531177
Healthy Eating & Active Lifestyles for Diabetes: Feasibility Trial (HEAL-D)
Healthy Eating & Active Lifestyle for Diabetes in UK African & Caribbean Communities: a Feasibility Trial With Process Evaluation
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Szczegółowy opis
This study is a feasibility trial with an embedded process evaluation of the HEAL-D intervention compared with usual care. The study will use a randomised controlled trial (RCT) design, with individual patients as the unit of randomisation, evaluating the HEAL-D programme against usual care. The RCT design has been chosen primarily to evaluate the feasibility of recruiting and retaining a control arm, as well as to define what constitutes 'usual care' and the variability within that. Patients with diagnosed type 2 diabetes (T2D) will be recruited from General Practice surgeries in the London Boroughs of Lambeth and Southwark. In addition participants from the phase 1 co-design study will be invited to participate and self-referral methods will also be used, for example posters and advertisements in community locations. Patients will be eligible if they have a documented diagnosis of T2D and are of self-declared African or Caribbean ethnicity. Patients with complex therapeutic dietary needs may be ineligible if their individual needs are deemed incompatible with the aims of the intervention. Additionally patients who are unable to communicate in English will be ineligible.
A pragmatic sample size of 80 randomised patients, 40 in each arm, is anticipated to be sufficient to evaluate the programme, allowing for 20% drop-out/non-completion. As this is a feasibility trial it is not powered to detect statistically significant intervention effects, unless these estimated effects are extremely large. The purpose of the study is to assess the feasibility and acceptability of the intervention and of trial methods, and to provide estimates of key parameters such as potential effect sizes, recruitment and retention rates of the trial and participation rates of the programme, so that the optimal design of a full-scale trial can be determined.
The HEAL-D intervention consists of 7 sessions; the programme will have a flexible schedule allowing participants to attend either fortnightly or monthly sessions. Each patient who participates will be in the study for approximately 7 months and will be asked to complete two assessment visits, one at baseline and one 6-8 months later, depending on the intensity of programme attendance. A range of potential primary and secondary outcome data will be collected including HbA1c, blood lipids (triglyceride, total cholesterol, HDL-cholesterol, LDL-cholesterol), body weight, waist circumference, diabetes knowledge, diabetes and dietary competence, diabetes empowerment, perceived social support, quality of life, dietary intake, and physical activity. Participants may also participate in an interview or focus group as part of the study's process evaluation.
Typ studiów
Zapisy (Rzeczywisty)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Lokalizacje studiów
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London, Zjednoczone Królestwo, SE1 9RT
- Guys and St Thomas Nhs Foundation Trust
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
Inclusion Criteria:
- documented diagnosis of type 2 diabetes
- self-declared African, Caribbean or Black British ethnicity
Exclusion Criteria:
- Complex dietetic needs e.g. advanced renal disease, making them unsuitable for general diet and lifestyle advice.
- Complex educational needs making them unsuitable for general group education.
- Unable to communicate in English.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
---|---|
Eksperymentalny: Intervention
HEAL-D diet and lifestyle education and behavioural change intervention, 7 sessions over 14 weeks.
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HEAL-D is a 7 session programme of self-management education and behaviour change support for African and Caribbean patients with type 2 diabetes.
The sessions will support participants with behaviour change to adopt evidence-based diet and physical activity targets for type 2 diabetes.
The intervention has been systematically developed with defined theory and behavioural change techniques mapped to this theory.
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Aktywny komparator: Control
Usual care.
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Participants receive usual care from their healthcare team.
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
---|---|---|
HbA1c
Ramy czasowe: 6 months
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glycosylated hemoglobin, mmol/mol
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6 months
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Waist circumference
Ramy czasowe: 6 months
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Waist circumference, cm
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6 months
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
---|---|---|
Body weight
Ramy czasowe: 6 months
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Body weight, kg
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6 months
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Total cholesterol
Ramy czasowe: 6 months
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Total cholesterol, mmol/l
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6 months
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LDL-cholesterol
Ramy czasowe: 6 months
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LDL-cholesterol, mmol/l
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6 months
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HDL-cholesterol
Ramy czasowe: 6 months
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HDL-cholesterol, mmol/l
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6 months
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triglycerides
Ramy czasowe: 6 months
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triglycerides, mmol/l
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6 months
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Diabetes knowledge
Ramy czasowe: 6 months
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Measured using the Short Diabetes Knowledge Instrument
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6 months
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Perceived Diabetes & Dietary Competence
Ramy czasowe: 6 months
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Measured using the Perceived Diabetes & Dietary Competence (PDDC) questionnaire
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6 months
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Diabetes Empowerment
Ramy czasowe: 6 months
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Measured using the Diabetes Empowerment Scale-Short Form (DES-SF).
It measures an individuals psychosocial self-efficacy with regard to their type 2 diabetes management.
It uses a 5 point scale: Strongly Disagree; Somewhat disagree; Neutral; Somewhat Agree; Strongly Agree Strongly Disagree has a score of 1 through to strongly agree with a score of 5.
The questionnaire is scored by averaging scores for all completed items.
Total score ranges from a minimum of 1 to a maximum score of 5.
The higher the score the higher the self-efficacy/empowerment.
There are no sub-scales in this measure.
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6 months
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Perceived social support
Ramy czasowe: 6 months
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Measured using the Multidimensional Scale of Perceived Social Support (PSS).
It measures the degree to which an individual feels socially supported.
Scores are on a numerical scale from 1 to 7 with 1 being the lowest social support and 7 the highest.
The scores are summed.
Three subscales are reported: family; friends; and significant other.
Each subscale scores a minimum 4 and maximum 28.
The total score ranges from 12 to 84.Higher scores indicate higher the degree of perceived social support.
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6 months
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Quality of Life
Ramy czasowe: 6 months
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The EuroQol Five Dimension Three Level (EQ-5D-3L) scale measures health status.
Level 1: respondents choose one statement which best describes their health status (5 dimensions: mobility, self-care, usual activities,pain/discomfort, and anxiety/depression), coded as 1 (no problems), 2 (some problems), or 3 (extreme problems).
Numerals 1-3 have no arithmetic properties and should not be used as a cardinal score.The person's health status is defined by a 5-digit number, ranging from 11111 (no problems in all dimensions) to 33333 (extreme problems in all dimensions).
There are potentially 243 different scores.
Level 2 is the Visual Analogue Scale giving a score from 0 to 100, higher values indicating better health.
The total score ranges from 0-1, it is calculated by applying a formula that essentially attaches values ('weights') to each of the levels in each dimension.
The index can be calculated by deducting the appropriate weights from 1, the value for full health (i.e.
state 11111).
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6 months
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Diabetes-specific Quality of Life
Ramy czasowe: 6 months
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Measured using the Problem Areas In Diabetes-5 point scale (PAID-5).
Each question has five possible answers with a value from 0 to 4, with 0 representing "no problem" and 4 "a serious problem".
The scores for each of the 5 questions are added up to give a total score ranging from 0 to 20, with higher scores indicating higher degree of problems with diabetes.
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6 months
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Dietary carbohydrate intake
Ramy czasowe: 6 months
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Measured in grams/day from a 24 hour recall interview
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6 months
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Physical activity
Ramy czasowe: 6 months
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Measured as minutes of moderate intensity exercise per day using the Motion Watch accelerometer
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6 months
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Współpracownicy i badacze
Sponsor
Współpracownicy
Śledczy
- Krzesło do nauki: Louise M Goff, PhD, King's College London
- Główny śledczy: Barbara McGowan, PhD, Guy's and St Thomas NHS Foundation Trust
Publikacje i pomocne linki
Publikacje ogólne
- Goff LM, Rivas C, Moore A, Beckley-Hoelscher N, Reid F, Harding S. Healthy Eating and Active Lifestyles for Diabetes (HEAL-D), a culturally tailored self-management education and support program for type 2 diabetes in black-British adults: a randomized controlled feasibility trial. BMJ Open Diabetes Res Care. 2021 Sep;9(1):e002438. doi: 10.1136/bmjdrc-2021-002438.
- Goff LM, Moore AP, Rivas C, Harding S. Healthy Eating and Active Lifestyles for Diabetes (HEAL-D): study protocol for the design and feasibility trial, with process evaluation, of a culturally tailored diabetes self-management programme for African-Caribbean communities. BMJ Open. 2019 Mar 1;9(2):e023733. doi: 10.1136/bmjopen-2018-023733.
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- HEAL-DV2
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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